MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL; ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG

Model Number	AGNX2XXX
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The holes in the hose could interfere with ventilatory support.
Event or Problem Description
Product integrity.
Additional Manufacturer Narrative
The holes in the hose could interfere with ventilatory support."based on the investigation and since no pictures or physical sample of fg agnx2xxx with lot number 0004258034 was provided we cannot confirm the reported defect since we requite the physical sample to perform a better investigation.The root cause was not established no corrective or preventive actions were taken.
Event or Problem Description
Product integrity.

• Brand Name: VYAIRE MEDICAL
• Common Device Name: ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG
• Manufacturer (Section D): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18823128
• Report Number: 8030673-2024-01000
• Device Sequence Number: 4525895
• Product Code: CAI
• UDI-Device Identifier: 10190752122741
• UDI-Public: 10190752122741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AGNX2XXX
• Device Catalogue Number: AGNX2XXX
• Device Lot Number: 0004258034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown